Articles injection molded on a web

ABSTRACT

Articles enabled by an injection molding process that molds parts on a carrier web located between mold halves and uses ultrasonic energy to assist flow of polymer melt into the mold cavity. One such article is a carrier web having a high density of molded parts, i.e., bearing an array of molded articles adhered to the web in rows and columns, the articles being spaced closer (center-to-center or edge-to-edge) than the diagonal spacing between articles in the next adjacent row and next adjacent column. Another such article is a microneedle array on a land no more than 250 μm thick on which at least 60% of the microneedles across the array are filled (i.e., completely formed).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of pending priorapplication Ser. No. 12/600,557 filed Jun. 18, 2008, now allowed, whichwas a national stage filing under 35 U.S.C. 371 of PCT/US2008/067318,filed Jun. 18, 2008, which claims priority to U.S. ProvisionalApplications Nos. 60/945,217 and 60/945,224 both filed Jun. 20, 2007,the disclosures of which are incorporated by reference in their entiretyherein.

TECHNICAL FIELD

The present disclosure relates to ultrasonic assisted molding methodsand related devices.

BACKGROUND

Molded articles are well known and commonly used. Molded articles havingdelicate structures thereon can be challenging to mold and subsequentlyprocess and handle. Injection molding small delicate structures istypically accomplished by injecting molten material into a mold cavityand applying additional heat to the molten material while in the moldand allowing additional time for the molten material to flow into thesmall cavities in the mold.

A method of molding microneedles is disclosed in InternationalPublication WO 2005/082596, and a method which may include the use ofultrasonic energy is disclosed in International Publication WO2006/062974. A method of molding parts onto a continuous web of flexiblematerial is taught in U.S. Pat. No. 4,921,671, and a method of makingcontainer caps on a thin sheet of plastic between upper and lower dieparts which are brought together while an annulus of plastic is injectedon said sheet is disclosed in U.S. Pat. No. 2,965,932. The use ofelectromagnetic induction to preheat molds is known.

DISCLOSURE OF INVENTION

The present disclosure provides methods of injection molding parts ontoa carrier web. Some embodiments of the disclosed method include theapplication of ultrasonic vibrations to a carrier web, which is indexedbetween the mold halves. The disclosure also provides a method ofprocessing and subsequently handling molded parts. Moreover, thedisclosure provides a molded array of devices on a web and the machinefor creating the molded devices.

The inventive method comprises:

-   providing an injection molding apparatus having a first mold member    and a movable mold member that can move toward and away from the    first mold member to close the mold, in which there is a mold    cavity, in at least one of the first or movable mold members, having    a plurality of microstructural features characterized by an aspect    ratio of at least 2:1;-   injecting a polymer melt into the mold cavity while it is closed;-   applying ultrasonic vibrations to the mold cavity by means of an    ultrasonic horn;-   and applying at least one set of process parameters selected from:-   A. positioning a carrier web so that, when the mold is closed, the    carrier web is between the first mold member and the moving mold    member, part of the web faces the mold cavity and part of it is    outside of the closed mold;-   B. heating the mold cavity by an electromagnetic induction heating    means; and/or-   C. heating the mold cavity by electric resistance heating.

Electromagnetic induction (EMI) heating can be used to apply rapid,localized heating of a microstructured tool within an injection moldcavity. EMI can be used to mold parts with sub-5 micrometer featuresthat excellently replicate a mold pattern in a relatively short moldcycle time (e.g., less than 10 seconds) and with significant reductionin in-mold stresses and birefringence in the molded article produced, ascompared with articles made without EMI.

“Microstructure” means microscopic features or structures (having atleast one dimension (e.g., length, width or height) between 1 μm and 1mm) on a larger article. Such features may be, for example cavities,grooves or projections (e.g., microneedles in a microneedle array on adisk of polymer (hereinafter called a land)).

Microneedles are small, tapered microstructures that arise from a baseor land of an article (e.g., a disc or circular base of a microneedlearray). The microneedles are elongated and tapered from base to tip andmay have a shape like a pyramid, cone or those shapes disclosed in U.S.Patent Publication 2003/0045837 and PCT Publication WO 2007/075614,among others. Microneedles can pierce the stratum corneum of the skin tofacilitate the transdermal delivery of therapeutic agents or thesampling of fluids through the skin. Height of a microneedle is normallyless than 1000 μm, typically in the range of 20-500 μm, or 25-250 μmfrom the base to the tip, and the aspect ratio may be in the range of2:1 to 6:1.

“Aspect ratio” means the ratio of height or length of a feature (such asa microstructural feature, like microneedles) to width or diameter atthe widest part of such feature (such as the base of a microneedle whereit intersects the land that serves as a base of a microneedle array). Inthe case of a pyramidal microneedle with a polygonal or rectangularbase, the maximum base dimension used to find apect ratio would be thediagonal line connecting opposed corners across the base.

An “array” means an arrangement of two or more articles or features on asurface in proximity to each other, which may or may not be in aparticular geometric order.

“Percent fill” is the depth of a single microstructural feature thatpolymer melt is able to fill. For example, if a microneedle cavity is250 μm deep and polymer fills it to a depth of 125 μm, percent fillwould be 50%.

An apparatus used in the inventive method comprises:

An injection molding apparatus comprising:

a first mold member;

a moving mold member that can move toward and away from the first moldmember;

a mold cavity within the first mold member and facing the moving moldmember;

a web handling means for moving a web between the first mold member andthe moving mold face so that part of the web faces the mold cavity andpart of the web is outside of the area enclosed by the first and movablemold members when they are in the closed position;

a means to inject melt into the mold cavity; and

an ultrasonic system for providing ultrasonic vibrations to the melt inthe mold cavity;

said apparatus further comprising at least one component selected from:

-   A. a web indexing means to index the carrier web to a different    position along its length each time the moving mold member moves    toward the first mold member to close the mold;-   B. an electromagnetic induction heater capable of heating a mold    insert within the mold cavity and/or metal surrounding the mold    cavity; and-   C. an electrical resistance heating means.

A positioning means, capable of positioning the EMI heater close enoughto the mold cavity to accomplish such heating if it is not already insuch a position, can be used. So long as the EMI heater can bepositioned close enough to effectively heat the mold cavity, otherconfigurations can be used. For example, an EMI heater can be locatedwithin the first mold member in a position close to the mold cavity. Inthat case, a positioning means as described above would be unnecessary.

With reference to a mold, the term “feature” means a three dimensionalcavity, recess, or depression within a mold cavity that may define, atleast in part, the shape of an article to be molded, such as amicroneedle or lens.

The filling of the very small features of a mold is aided by dynamicmold temperature cycling which controls the use of heat transfer meansto adjust mold temperature. In dynamic mold temperature cycling, themold is first heated to a temperature above the softening temperature ofthe polymer to be injected (e.g., above 149° C. for polycarbonate). Highmold temperature helps to keep polymer melt viscosity low to facilitatefilling the mold features and minimize viscoelastic skinning. Afterformation of the molded part, the mold is cooled below the softeningpoint to help solidify the molten polymer. Methods of mold temperaturethermal cycling are described in PCT Publication WO 2005/082596 and U.S.Pat. No. 5,376,317.

The efficacy of dynamic mold temperature cycling is limited by the rateof mold heating and cooling. Highly thermally conductive materials(e.g., beryllium-copper alloys) can be used to improve heat transfer,but the rate of heat transfer is limited by the properties of the heattransfer means used, such as oil.

The term “cycle time” means the time from closing of the injectionmolding apparatus, with the carrier web between the first and movablemold members, until the indexing of the carrier web, moving the moldedarticle or articles away from the mold cavity area and positioning partof the carrier web for the next mold cycle. During each mold cycle, thecycle time should be sufficient to allow the mold cavity (including anymicro-cavities in the insert) to be substantially filled with moltenpolymer and for the polymer to subsequently cool below the polymersoftening point.

In the inventive method, filling mold features is also aided by use ofultrasonics and/or EMI heating of mold parts as part of the moldingcycle. After the polymer melt has filled the mold cavity, the mold iscooled to a temperature below the polymer glass transition temperatureto allow for ejection of the molded article from the cavity. Thecombination of process parameters in the inventive process enableshorter mold cycle times than are practical by practicing the prior art.The inventive process and apparatus enable injection moldingmicrostructured articles (having features with dimensions of less than 5μm) with good fidelity (i.e., good reproduction of the very small moldfeatures) and mold cycle times of 20 seconds or less.

To maximize molded part density on a carrier web the inventive processcan be configured to mold cavities in staggered positions on the carrierweb. This concept, to be explained hereinafter, can yield an array ofmolded articles adhered to the carrier web in which the closestcenter-to-center, or edge-to-edge, distance between the molded articlesis closer than the center-to-center, or edge-to-edge, distance betweenthe mold cavities of the injection molding apparatus.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic side view of a molding system according to theprinciples of the present disclosure;

FIG. 2 is a schematic cut-away view of a mold cavity in a closedposition showing articles molded on a first side of a carrier web;

FIG. 3 is a schematic cross-sectional view of a mold cavity showingfeatures molded on a first side and a second side of a carrier web;

FIG. 4 is a schematic perspective view of a first mold side and a secondmold side;

FIG. 5 is a top view of a plurality of articles on a carrier medium;

FIG. 6 is a side view of a part being pulled from the mold cavity ofFIG. 2;

FIG. 7 is a schematic cross sectional view of the mold sides of FIG. 4;

FIG. 8 illustrates partially rolled up carrier web having a plurality ofmolded articles thereon;

FIG. 9 depicts parts on a carrier web being further processed;

FIG. 10 is a top view of a microneedle array on a carrier web;

FIG. 10 a is a detail showing microneedles of the microneedle array;

FIG. 11 is a cross-sectional view of the microneedle array of FIG. 10;

FIG. 12 is a cross-sectional view of an alternative embodiment ofmicroneedle array of FIG. 11;

FIG. 13 is a schematic view of an injection molding apparatus nozzlearrangement to obtain the arrangement of molded articles on a carriermedium in FIG. 5;

FIG. 14 is a front view of a mold cavity showing parting lines vents andoverflows;

FIG. 15 is a partial sectional view of the mold cavity of FIG. 14.

DETAILED DESCRIPTION

Referring to FIG. 1, a schematic view of an injection molding system 10according to an embodiment of the present disclosure is shown. In thedepicted embodiment, the system 10 includes a hopper 12 for receivingthe material to be melted (e.g., plastic or metal pellets encased inplastic), a motor 14 for powering the system, a heated chamber 16 formelting and feeding the material, a first mold member 18, and a secondmold member 20 in which ultrasonic horn 42 is installed. In the depictedembodiment the first mold member 18 is stationary (although it could bemovable) and the second mold member 20 moves towards and away from thefirst mold member 18.

The molding system 10 further includes a web indexing system 22. In thedepicted embodiment the web indexing system includes a feed roll 24, anuptake roll 26, a pull roll 32, and a number of guide rollers 25 and 30between the feed roll 24 and uptake roll 26. The indexing system 22 isconfigured to move a web 34 between the first mold half (first member)18 and second mold side or movable mold member 20. The web 34 isreferred to interchangeably herein as a film or carrier web. Indescribing location or movement with respect to the carrier web,location or movement in the direction in which the web is being movedalong its length is called “down-web”, and a location or movement in theopposite direction (toward the direction from which the web is beingunwound) is called “up-web”.

Though typical injection molding systems do not include a web indexingsystem, it should be noted that a system wherein a web is passed througha mold is described in PCT Publication No. WO 2007/075806 titledManufacturing Microneedle Arrays, which is herein incorporated byreference in its entirety. It is within the skill of the art to design aweb indexing system to index carrier web 34 between mold members 18 and20. Web indexing systems are known in the art as exemplified by U.S.Pat. Nos. 4,848,630 and 5,470,300.

An electromagnetic induction heater 15 is shown between the first moldmember 18 and web 34. EMI heaters are known, and this one has aninduction coil housing 19 containing an electromagnetic induction coil.Induction heater 15 is attached to arm 17 that is attached to anactuator (not shown) to raise and lower the induction heater andposition it close to first mold member 18. In one embodiment of theinventive molding process, the EMI heater is placed in close proximityto the mold cavity (e.g., >0-2 mm gap between the face of the mold plate37 (see FIG. 2) and induction coil housing 19) to provide rapid,localized heating of the surfaces of the mold cavity and insert.Electromagnetic induction heating is used in conjunction with dynamicmold temperature cycling (discussed above). In the injection molding ofarticles with micro- or nano-features, the temperature of the surfacesto which the polymer melt is exposed can affect the quality of themolded article, and EMI heating combined with dynamic mold temperaturecycling is used as a means to rapidly raise that surface temperature foreach mold cycle.

EMI heating apparatus are available commercially from such companies asMSI Automation, Inc., Wichita, Kan., U.S.A. A typical EMI heater wouldhave a power of 1-5 KW and provide output frequency in the range of25-450 KHz for surface heating. In the development of this invention anEMI apparatus was used having the following characteristics:approximately a 2.54 cm. diameter, water cooled, copper induction coilsurrounded by a ceramic housing, (about 3.18 cm diameter and 4.45 cmlong) 1500 W power, actual power used being 700 to 1250 W (depending onthe power setting which ranged from 1 to 10), 120 Volts, 13 Amps and 25to 50 kHz of output frequency. A reasonable range of induction heatingtime is 6 to 12 seconds for the system described herein. The diameter ofthe circular mold cavities 33 (see FIG. 2) in the apparatus used indeveloping this invention was about 12.7 mm. The EMI apparatus used waslarger in diameter than needed. Ideally, a smaller EMI heater would beused having a surface approximately congruent with the mold cavity ormold cavity cross section.

With the use of a 1500 W EMI heater, with induction power settings about50% of maximum power capacity, a mold insert for microneedles reachedtemperatures between 121° and 177° C. which is useful for moldingmicroneedles from polycarbonate. Because EMI heating is focused on thesurface of the mold cavity or insert, rapid heat dissipation (e.g., intothe mass of surrounding metal and heat transfer fluid) can occur afterfilling the mold cavity. In general, gaps between the electromagneticinduction coil housing and the mold plate face in the range of about 1.5to 2 mm led to approximately similar temperature profiles (i.e., curveof insert temperature vs. induction coil power setting); whereas, at asmaller gap of 1016 μm, the resulting temperature increase in the moldinsert was higher at comparable induction activation times (3-8seconds).

Referring to FIGS. 2 and 3, cross-sectional views of embodiments of amold cavity are shown and described in greater detail. FIG. 2 depicts anembodiment wherein the molded article 46 is located on only the firstside 48 of a carrier web 34. FIG. 3 depicts an embodiment wherein themolded features 50, 52 are located on both the first side 48 and thesecond side 44 of the carrier web 34.

The polymer used in the injection molding process to make moldedarticles may comprise a variety of polymers selected based on propertiessuch as ability to accurately reproduce the desired pattern of the moldcavity and insert, strength and toughness of the molded polymer, andcompatibility of the molded polymer with the intended use. For example,one might choose a polymer or polymer blend or compound capable offorming relatively rigid and tough microneedles that resist bending orbreaking in use. Some useful polymeric materials have: a melt-flow indexgreater than 5 g/10 min., 10 g/10 min., or 20 g/10 min. measured by ASTMD1238 at 300° C. and 1.2 kg. weight; a tensile elongation at break(measured by ASTM test D638 (2.0 in/min.)) greater than 100%; and impactstrength (measured by ASTM D256, “Notched Izod” 23° C. greater than 5ft-lb/inches. Some useful polymers are: polyphenyl sulfides,polycarbonates (e.g., Lexan HPS1R resin from Sabic Innovative Plastics,Pittsfield, Mass.), polypropylenes, acetals, acrylics, polyetherimides,polybutylene terephthalates, polyethylene terephthalates, and blends ofsuch polymers.

The temperature of the metal surfaces of the mold cavity during fillingand packing of the polymer melt into the cavity depends on the polymerused. Temperature is desirably sufficiently high to yield a low meltviscosity to improve the flow of polymer into microstructure cavities ofthe mold, but not high enough to degrade the polymer. Typical moldtemperatures for molding polycarbonate are in the range of 60° C. to200° C. or 120° C. to 175° C. during filling and packing, and in therange of 65° C. to 120° C. during ejection of a molded part from themold. Temperature can be controlled by heat transfer means such aselectric resistance heating near the mold cavity and/or heat transferfluid (e.g., in a tube or tubes) in close proximity to the mold cavity(e.g., oil in a temperature range of 60°-150° C. or water in atemperature range of 27°-60° C.). One form of electric resistance heatcomprises making electrical connection with the metal mold insert (e.g.,insert 38 in FIG. 2) and using the insert itself as a resistance heater.In such an arrangement, a high current, low voltage transformer can beused so supply electricity to the resistance heater, e.g., about 40-150amps and about 0.5-4 volts. The mold cavity may also be heated by otherknown means, such as: radiant energy, e.g., infrared energy or laser; orhot air flow from a heat gun.

Referring particularly to FIG. 2, the carrier web 34 is shown betweenfirst mold member 18 and a movable mold member 20. The carrier web 34 inthe depicted embodiment is constructed of a polycarbonate film, however,it should be appreciated that the web 34 can be constructed of manyother different materials (eg., metal foil, porous or non-porouspolymer, woven, non-woven or knitted cloth composite, etc.). For carrierwebs in this process, the term “composite” means a web comprising morethan one raw material, such as a web made of both metal and polymer orlaminates of metal and polymer film, cloth and polymer, or paper andpolymer. Examples of suitable polymers for the carrier web are:polypropylenes, polycarbonates, polyethylenes, polyimides andpolyesters. Carrier web thickness may be in the range of 5 to 1250 μm,or between 25 and 500 μm, and is preferably less than 250 μm.

By using a carrier web, the use of sprues and/or runners (common ininjection molding, but wasteful of expensive polymer) can be minimizedor eliminated. The carrier web eliminates the need for a cold runner forhandling molded parts after ejection from a mold. The carrier webbetween the movable and first mold members can also serve as aninsulator, resisting heat transfer from the mold cavity, helping retainheat which has the effect of keeping the polymer melt at a lowerviscosity for a longer time.

In the depicted embodiment the first mold member 18 includes aninjection gate 36, connected to a hot manifold nozzle 35, which directsmolten material directly into the mold cavity 33. Although gate 36 is inthe center of cavity 33 which is circular, there could be otherlocations for the injection gate, and locating the gate (or gates) iswithin the skill of the art. In the depicted embodiment the mold cavity33 is within mold plate 37 which is attached to first member 18. The hotmanifold nozzle 35 functions via the retraction of a pin which opens theexit of the nozzle and releases the polymer melt into the mold cavity.The insert 38 includes a cavity-facing surface 40 that includesmicro-cavities 39 therein (e.g., cavities used to form microneedles).While it is inside the mold cavity, the insert is considered part of thecavity. A mold insert (sometimes called a stamper) used to makeinjection molded microneedles (or other articles having microstructure)can comprise a nickel tool electroformed in the shape of a negative of amicroneedle array (see WO 2005/082596, pages 6 and 9). The moldconfiguration with insert 38 enables the same mold cavity 33 to be usedto mold a number of different articles 46 by exchanging the mold insert38 for one of a different shape or with different details.

In the inventive process, the mold cavity 33 is closed by moving themovable mold member 20 into contact with carrier web 34, clamping themold with sufficient force provided by the injection molding machine.Then, polymer melt is injected into the mold cavity, and pressure may beused, in part, to fill the mold cavity with the melt. Part of theinjection of polymer melt into the mold cavity may be based on reachinga certain pressure within the mold cavity (“pack pressure”). Packpressure (e.g., in the range of 3.5 to 414 megaPascals (MPa) or 34.5 to138 MPa) is applied for a finite time (referred to as “hold time”). Apressure above 103 MPa may be used to achieve uniform filling of themold micro-cavities. Pack pressure is released, and the material withinthe mold cavity is cooled to an ejection temperature normally at orbelow the polymer softening temperature. Then, the mold members areseparated, and the molded article is ejected from the mold cavity.

Useful parameters for the inventive process are: injection velocity of60-360 mm/sec; pack pressure of 3.5-207 MPa, preferably 103-138 MPa;hold time of 0.5-10 seconds; mold temperature at injection (forpolycarbonate) of 49°-150° C., preferably less than 121° C.; moldtemperature at ejection (for polycarbonate) of 49°-138° C., preferablyless than 121° C.

In the depicted embodiment, the movable mold member 20 of the injectionmolding apparatus includes a mechanism for applying auxiliary energy tothe molten material while the molten material is inside the mold cavity.In the depicted embodiment the mechanism is an ultrasonic horn 42, whichis configured to produce ultrasonic vibration energy. The ultrasonichorn used in developing this invention was solid, but it may be hollow.Materials of construction for the horn are within the skill of the art,but are typically titanium, aluminum or steel. The horn used indeveloping this invention was titanium.

In the depicted configurations, carrier web 34 is pressed against thehorn 42 which directs ultrasonic vibration to the second side 44 of theweb 34. The ultrasonic vibrations are transmitted through the web 34 tothe molten material within the mold cavity. Ultrasonic vibrations may beused during the velocity-pressure switchover in the injection moldingprocess (period when the injection molding machine is switching fromfilling the mold cavity with polymer melt to building pressure withinthe cavity).

Frequency of the energy can be in the range of 5,000-60,000 Hz, possibly10,000-60,000 Hz, more typically 20,000 Hz-60,000 Hz, or 20,000-40,000Hz. For a 20,000 Hz frequency, the peak-to-peak vibrational amplitude ofhorn 42 is typically less than 127 μm and can be less than 51 μm.Amplitude is a function of horn shape and excitation input. Amplitude inthe range of 7.5 and 15 μm has been found useful. The ultrasonic energyis generally supplied by using a power source (e.g., in the range of 500to 5000 Watts) to supply electrical energy of the desired frequency.Electrical energy is fed to a converter or transducer that transforms itinto vibrations which can be amplified or boosted and transmitted viathe horn.

The energy imparted to the molten material causes the material tofurther flow within the mold cavity. The horn transfers energy to thepolymer melt so that it flows more readily into the micro-cavities ofthe mold insert. Locating the injection gate 36 in the center of thecavity has the advantage of reducing the wattage or energy required inapplying ultrasonic vibrations, as compared to other gate locations(e.g., at the perimeter of the cavity). This allows the potential formore mold cavities to use the ultrasonic energy supplied by a singlepower supply (e.g., 5000 W).

The attachment of molded articles to the carrier web is affected by theamplitude of the ultrasonic vibrations. For example, when usingpolycarbonate film and polycarbonate melt material, peak-to-peakamplitude of 2.5-7.5 μm provides a weak bond between molded articles andthe carrier web; while also giving a percent fill below 50%. Amplitudesbetween 7.5 and 15 μm yield good bond strength between the moldedarticle and the carrier web along with improved percent fill(e.g., >75%). Amplitudes above 15 μm give excellent bond strength andenhanced percent fill (e.g., >85%). After the molded articles 46 on thecarrier web 34 are formed, that portion of web 34 carrying the moldedarticles is indexed out of the mold and a new portion of the web 34 isindexed into position facing the mold cavity.

Referring particularly to FIG. 3, molded features 50, 52 are depicted onboth the first side 48 and the second side 44 of the carrier web 34. Thedepicted embodiment includes injection gates 56, 54 on each of the firstmold member 18 and movable mold member 20, and a horn 58 is included onthe movable side 20. It should be appreciated that many alternative gateand horn configurations are possible. In the depicted embodiment themold feature 50 has a domed cross-sectional shape and the mold feature52 has a rectangular cross-sectional shaped. Moreover, the features 50,52 are opposite each other and cooperatively form a useful device (e.g.,an optical lens). It should be appreciated that in alternativeembodiments the features 50, 52 on either side of the carrier web 34 canbe the same or different in shape and/or material. It should also beappreciated, that in alternative embodiments the features 50, 52 do notneed to be opposite each other on the carrier web 34.

In an alternative embodiment the carrier web can include perforations orone or more slits or holes therein that enable the melt to flow from oneside of the web to the other side of the web. The carrier web may alsohave surface grooves or texture sufficient to allow venting of the mold.One may use sufficient injection pressure to inject polymer melt throughthe carrier web into a cavity on the opposite side of the web from thegate. According to such embodiments, mold features can be formed on bothsides of the web with injection gates being on a single side of the web.It should also be appreciated that in alternative embodiments the gates56, 54, can feed molten material into the mold cavity from many otherdirections (e.g., top, bottom, and sides).

Some lenses include features of low aspect ratio on one side andrelatively high aspect ratio on the other. With a carrier web betweenthe first and movable mold members, the low aspect ratio side of a lensmay be embossed on the side of the web facing the movable mold member bya coining stroke. On the other side of the web, polymer melt is injectedinto the mold cavity, and the same coining stroke may simultaneouslyform the shallow or low aspect ratio part of the lens and high aspectratio side of the lens under compression. By using the carrier web aspart of the lens, the lens can be transported to a next manufacturingoperation attached to the carrier web. This reduces handling and damageto the lens such as scratches and facilitates assembly. The compressionor coining stroke allows thin lenses to be molded. Ultrasonic vibrationsutilized during the mold cycle can increase the sharpness of detail,decrease the stress within a molded article, and allow thinner lenses tobe molded.

Referring to FIG. 4, the first and movable mold members 18, 20 are shownin a perspective view. The depicted embodiment illustrates that aplurality of separate molded articles can be simultaneously molded ontoa carrier web. There can be 4, 8 or even 32 or more cavities in aninjection mold, and it is advantageous to mold as many articles in asingle mold cycle as possible. In the depicted embodiment the mold sides18, 20 are configured to simultaneously mold eight separate articlesonto a carrier web 34. In some embodiments the articles can beidentical, whereas in other embodiments they can be different. Thedepicted embodiment further illustrates that the faces of ultrasonichorns 60, 61 can surround a plurality of mold features. In the depictedembodiment two circular-faced ultrasonic horns are located on themovable mold member 20. It should be appreciated that in alternativeembodiments ultrasonic horns could be located on one or both of the moldsides.

Referring to FIGS. 5 and 13, a web carrier 34 is shown with a pluralityof molded articles X₁ and X₂ thereon. The carrier web 34 serves as asupport structure that allows the articles X₁ and X₂ to be handled as agroup without actually picking and placing the articles separately. Thecarrier web 34 also serves the function of keeping the articles X₁ andX₂ oriented with respect to each other. In some embodiments runnersbetween the articles X₁ and X₂ are used to maintain the orientation ofthe articles once they leave the mold. In the depicted embodiment theshortest or lateral distance between the articles X₁ and X₂ is abouthalf the diagonal distance between adjacent mold cavities on the moldmembers. This is accomplished by molding articles X₁ and X₂ in twoseparate steps. For example, articles X₁ can be molded on the webcarrier 34 in a first molding cycle, and then the web carrier witharticles X₁ thereon can be indexed through the mold to a new position tomold articles X₂ onto the web carrier 34. In FIG. 5, arrow A shows thedirection of carrier web movement, outline B shows the approximateperimeter of the first mold member 18, and S is the distance by whichthe carrier web is indexed from the mold cycle for articles X₁ to thenext position for the mold cycle for articles X₂.

In FIG. 13, 35 a represents the location of a manifold nozzle likemanifold nozzle 35, but to inject polymer melt into a mold cavity in thenext adjacent row of molded articles as shown in FIG. 5. Clearancecavities, such as cavity or offset 41 shown in FIG. 13, can be designedinto the mold plate and first mold member to permit close positioning ornesting of molded articles and more efficient use of the web carrier. Itshould be appreciated that many other types of arrangements on the webcarrier 34 are also possible. The same principle can be used in moldingon both sides of the carrier web by designing movable mold member 20with an offset to accommodate molded features on the side of the carrierweb facing movable mold member 20.

The staggered or offset position of parts X₂ being molded at the sametime shown in FIG. 5 allows room for the necessary components to supporteach mold cavity (such as the gate, manifold nozzle and heat transfermeans such as tubes through which water or oil flow). Experience in thedevelopment of this invention indicates that a minimum spacing betweenmolded articles on a carrier web could be as small as 5 mm.

Referring to FIG. 6, a side view of a molded article 62 is shown beingremoved from the first mold member 18. In the depicted embodimenttension is applied to the web in a direction away from the first moldmember 18 to pull the molded article 62 out of the mold cavity. Itshould be appreciated that ultrasonic vibrations may be used togetherwith the tension to facilitate the release of the molded article 62 fromthe mold cavity. Although the carrier web enables removal of a moldedarticle from the mold by means of the tension in the web alone, withoutusing mechanical ejector means such as ejector pins, lifters or astripper plate, in alternative embodiments pins or lifters may also beused in conjunction with or in place of the ultrasonic vibration andtension in the carrier web 34 to remove the molded articles 62 from themold side 18. In a further embodiment, air pressure or vacuum assistedforces may be used in conjunction with or in place of the ultrasonicvibrations or tension in the carrier web 34 to remove the moldedarticles 62 from the first mold member 18.

Referring to FIG. 7, cross-sectional views of the mold sides of FIG. 4are shown. The first mold side 18 is a stationary side with hot manifolddrops 64, 66, 68, 70 directed to each of the mold cavities 71, 72, 73,and 74. The second mold side 20 is configured to move towards and awayfrom the first mold side 18. In the depicted embodiment the movable moldmember 20 includes an ultrasonic system for providing ultrasonicvibrations to the melt. The ultrasonic system includes horns 60, 61 thatare connected to boosters 76, 78 which are connected to converters 80,81. Ultrasonic horns 60 and 61 are oriented axially (ultrasonicvibration is in the same axial direction as the input excitation, i.e.,vibrating along the axis of the horn). The horns have raised pads 59(e.g., larger in diameter than the mold cavities and raised about 250 μmabove the circular surface of the horn) on the side facing the moldcavities, and the horns are approximately aligned with and larger indiameter than a circle surrounding the mold cavities. The horns aremounted within movable member 20 by clamping at nodal flanges or rings75, leaving clearance between the horns and the surrounding parts of themovable member.

It should be appreciated that the illustrated configuration is anexample configuration. Alternative configurations can include differentinternal components or a different layout of the similar components or adifferent ultrasonic vibration direction. The horn may be oriented in aradial mode, for example. Although the ultrasonic horns in the drawingsare illustrated on the same side as the movable mold member, the horn orhorns could be located on the same side as the first mold member or inanother location; so long as the horn is located and oriented in aposition effective to direct ultrasonic vibrations into the polymer meltin the mold cavity.

Referring to FIGS. 8 and 9, a method of handling and processing moldedarticles is shown. In particular, FIG. 8 depicts a method of packingmolded articles by rolling the carrier web 34 onto itself. In thedepicted embodiment spacers 82 are used to protect the molded articlesfrom damage that might result from contact with the web carrier 34. Inthe depicted embodiment the spacers 82 themselves can be molded onto thecarrier web. In an alternative configuration, the carrier web may bethermoformed in the molding process to provide spacers 82. It should beappreciated that alternative embodiments may not include spacers, as themolded articles may be configured such that contact with the carrier web34 is unlikely to cause damage to the molded articles. It should also beappreciated that the carrier web 34 need not be rolled onto itself forpacking and shipping. In alternative embodiments the carrier web 34 canbe cut into sections and stacked one on top of the other for packing,shipping, processing, and handling purposes. In other alternativeembodiments the carrier web 34 can be fan folded onto itself forpacking, shipping, processing, and handling purposes.

FIG. 9 depicts the carrier web 34 with molded articles 84 thereon inprocessing steps subsequent to the molding process. In the depictedembodiment the carrier medium 34 provides a structure upon which themold features 84 on molded articles 62 are formed. It also provides ameans for handling the molded features 84 in a coating or a dryingprocess. For example, molded articles can be coated by passing them overa roller 86 positioned above a tank of coating liquid 88. The moldedarticles can by dried by passing them over a roller 90, which directsthe carrier web 34 past a drying device 92. The molded articles can alsobe inspected or sterilized while on the carrier medium.

Referring to FIGS. 10 and 11, a molded article is shown and described ingreater detail. The depicted embodiment includes a sheet 94 having a topsurface 96 and a bottom surface 98. A molded article 100 is shown fusedto the upper surface 96 of the sheet 94. In the depicted embodiment thesheet 94 is a flexible polymeric sheet (e.g., polycarbonate) that ismelted to the article 100 (e.g., the sheet and the article can beultrasonically welded together). A single article 100 is shown, but itshould be appreciated that a plurality of such articles 100 can bespaced apart on the sheet 94. In the depicted embodiment the moldedarticles 100 include an array of microstructures thereon. In particular,the molded article 100 includes an array of microneedles thereon. In thedepicted embodiment the height H of the needles is between about 25 to5000 microns and the distance W from peak to peak (also called pitch) isbetween about 25 to 5000 microns.

The lower part of the article that serves as the base from which themicroneedles rise is called the land, and distance L is the thickness ofthe land. Land thickness is determined by the dimensional relationshipbetween the mold insert (having the microstructure defining themicroneedles) and the depth of the mold cavity. The inventive processenables the manufacture of articles with a very thin land (e.g., L ofabout 250 μm or less). Lands about 50 μm thick, which can be made bythis method, can enable an array of microneedles that has goodconformability to the skin. It should be appreciated that numerous otherarticles are also possible, including articles that do not includemicrostructures thereon.

Referring to FIG. 12, an alternative embodiment of the articles of FIGS.10 and 11 is shown. In the depicted embodiment the molded devices 102are not fused with the sheet 104. In the depicted embodiment the moldeddevice 102 and the sheet 104 are constructed of different materials andare connected in an interlocking manner. For example, the molded device102 can include a polymeric or metal construction and the sheet 104 mayinclude a paper construction or metal construction (e.g, metal foil).The devices 102 are melted onto the sheet 104 such that they interlock.The devices 102 could in alternative embodiments interlock with eachother (e.g., in-mold assemblies are possible). In the depictedembodiment the sheet includes undercut features, but it should beappreciated that alternate configurations are possible (e.g., the sheetcould include projections that the molded devices 102 are molded aroundor the surface of the sheet may be porous for example paper). In someembodiments it is desirable for the device 102 to be easily separatedfrom the sheet 104, and in other embodiments it is desirable for thedevices to be difficult to separate from the sheet 104. The geometricconfiguration can be varied depending on the desired type of connectionbetween the devices and the sheet 104. In the depicted embodiment thesheet itself is embossed on the back side. Such embossing can occur aswhen the mold sides 18, 20 are pressed together during the moldingprocess. In some embodiments the embossing is used to provide an easyway to visually identify the device 102. In an alternative embodimentthe carrier web includes a shape that is thermoformed thereon instead ofembossed.

FIGS. 14 and 15 illustrate a mold cavity that can be used for moldingarticles with an overflow vent (see WO 2007/075806, page 11) to increasethe likelihood of filling all the small features within the cavity. Withthe use of an overflow vent, the quantity of polymer melt injected intothe cavity is greater than the quantity required to fill the cavity. Theexcess polymer can flow out through a venting means, such as flowingover mold overflow gate 110 into overflow channel 111, from thereexiting through primary vent 113, secondary vent ring 115 and vent 116which vents outside of the mold. The dimensions of these items arewithin the skill of the art, but example depths would be: overflow gate381 μm; overflow channel 762 μm; primary vent 127 μm; and secondary ventring and vent 762 μm.

The inventive process which combines ultrasonics and injection moldingon a carrier web can be operated at a shorter mold cycle time than knownprocesses. The cycle time typical of an injection molding process makingmicroneedles using only dynamic mold temperature cycling is 60-80seconds. Data have shown cycle time for an injection molding processmaking microneedles using runners between molded articles and ultrasonicvibrations to assist in filling the mold cavity of 14.0 seconds. Datahave shown cycle time for the inventive process making microneedles andusing a carrier web without runners of 12.0 seconds which is asignificant improvement.

Benefits of the inventive process and apparatus include:

-   1. Indexing of the carrier web enables the process to place a larger    number of relatively small molded articles per unit area of the web    than would otherwise be feasible (i.e., greater molded part density    on the web). This greater utilization of web area may make the    process more economical or make it more feasible to use expensive    web materials, such as printed circuit web.-   2. Mold cycle time reduction discussed above.-   3. The ability to mold articles, such as microneedle arrays, having    a thinner land portion than could previously be made by injection    molding in a very short mold cycle. Thinner microneedle arrays may    have an advantage in innoculation or injection applications using    certain types of apparatus in which low mass microneedles are    desired.-   4. The ultrasonic horn must be free to vibrate while the molding    machine is closed, and there is a certain clearance (e.g., in the    range of 25-50 μm) around the horn (between the horn and surrounding    parts in which the horn is mounted or installed) to allow it to    vibrate. When the horn or horns are located as shown in FIGS. 2-4,    and 7 within the movable mold member, the carrier web between the    movable and first mold members can serve as a gasket sealing the    mold cavity but allowing the horn to vibrate. The carrier web can    prevent molten polymer from leaking into clearance space around the    horn and creating mold flash. There is a balance between sufficient    clearance around the ultrasonic horn for it to vibrate under the    conditions of injection molding and avoiding a space large enough    for polymer melt or carrier web to flow into the clearance. That    balance can be determined by a person of skill in the art given the    information herein, and the dimensions stated in this description    are appropriate for that balance.-   5. Percent fill at short cycle times is improved over known methods.-   6. Percent uniformity (extent to which the microstructural features    across an entire array are filled) is improved over known methods.    For example, in molding a multiplicity of microneedles in a single    mold cavity, the microneedles furthest from the mold cavity gate    (where polymer melt enters the cavity) are generally most difficult    to make, i.e., for the polymer melt to reach and fill. The inventive    method enables filling these microneedles.-   7. Injection molding of microneedles or other articles on a web    facilitates downstream processing. In an ordinary injection molding    process, molded parts ejected from a molding apparatus are dropped    into a container from which they may be picked (e.g., by a robot)    for later steps. In the inventive method, molded microneedle arrays    may be transported on the carrier web to a next step such as coating    microneedles. The arrangement of molded articles on the carrier web    is advantageous in designing downstream steps.

It was not certain that injection molding on a carrier web could besuccessfully combined with the application of ultrasonics to improve themolding process. There was some concern that a carrier web would notsurvive the process conditions of injection molding pressures,temperature changes and the impact of ultrasonic energy. The inventivemethod and apparatus have overcome this concern.

The following example is illustrative and should not be construed aslimiting the invention in any way.

EXAMPLE

An 8 cavity center gated hot runner mold was used to deliver moltenpolycarbonate resin at 293° C. to a circular mold cavity containing aninsert having 1288 microcavities for microneedles 250 μm tall with anaspect ratio of about 3, a pitch (W) of 275 μm and tips having a 5 μmradius, to be molded on a circular land or disc about 1.4 cm indiameter. Experiments were conducted with and without EMI heating usinga pneumatically driven linear actuator to place an external 1500 W EMIheater between the first and movable members of the injection mold.Electromagnetic induction was applied for periods ranging from 3 to 8seconds using a gap of 1 mm between the end of the induction coilhousing and the plane of the mold plate face. A hot manifold system wasused to feed polymer melt to the mold cavities via the hot runners. Apolycarbonate carrier web was indexed between the first and movable moldmembers.

Vertical movement of the linear actuator for the electromagneticinduction heater was driven by a two-way solenoid valve operating withpressurized air (689 kPa) and was actuated using the robot interface ofthe 100 ton injection molding machine. The steps of the experimentswere:

1. The EMI heater was placed precisely in relationship to the moldcavity, and it was activated.

2. The EMI heater was returned to a home position outside of the spacebetween the first and movable mold members.

3. The mold was closed by moving the movable member toward the firstmold member to close the mold with the carrier web between the movableand first members, and polymer melt was injected into the mold cavities.

4. Ultrasonic energy was applied by a cylindrical, axially oriented hornat 20 KHz.

5. The movable mold member moved back from the first mold member, andthe molded articles separated from the mold cavity by means of thetension of the carrier web, followed by indexing of the carrier web inpreparation for the next plastic shot.

The fidelity of the injection molded articles made in the cavity heatedby EMI is shown in the table below. Ten replicas were made for eachprocess condition reported.

Induction Percent Percent Activation Time Microneedle Height UniformityFill 3 sec. 230 μm (+/−) 10 μm 60% 100% 5 sec. 240 μm (+/−) 10 μm 90%100% 8 sec. 250 μm (+/−) 5 μm  100%  100%

It is believed that, because the temperature difference between thepolymer melt and the mold cavity surface is reduced (by comparison withknown techniques) when EMI is used in the inventive process, theresulting molded article will not experience shrinkage to the sameextent as parts molded in conventional processes. Articles made withoutEMI display an interference pattern when viewed under a 45° crosspolarizer indicating anisotropy; whereas, a microneedle array made usingEMI as described above showed a distinctly different pattern underpolarized light indicating a reduction in anisotropy. With the use ofEMI, in-mold stress due to shrinkage is mitigated.

The above specification, examples, and data provide a completedescription of the manufacture and use of the inventions. Manyadditional embodiments of the inventions can be made without departingfrom the spirit and scope of the inventions. For example, this inventioncan be carried out using a stack mold configuration.

What is claimed is:
 1. An article comprising the combination of acarrier web (34, 94) and an array of molded articles adhered to thecarrier web which articles are characterized by microstructural featureshaving an aspect ratio of at least 2:1 said array comprising columns ofmolded microneedle arrays aligned in the down-web direction and rows inthe cross-web direction and in which array the closest center-to-center,or edge-to-edge, distance between the molded microneedle arrays iscloser than the diagonal center-to-center, or edge-to-edge, distancebetween a molded microneedle array and another molded microneedle arrayin the next adjacent row and the next adjacent column.
 2. The article ofclaim 1 on which the molded articles comprise a polymer selected fromthe group consisting of polyphenyl sulfides, polycarbonates,polypropylenes, acetals, acrylics, polyetherimides, polybutyleneterephthalates, polyethylene terephthalates and blends thereof.
 3. Thearticle of claim 1 of which the carrier web comprises a materialselected from the group consisting of metal foil, porous or non-porouspolymer, woven, non-woven or knitted cloth, or composites of suchmaterials.
 4. The article of claim 1 of which the carrier web comprisesa polymer selected from the group consisting of polypropylenes,polycarbonates, polyethylenes, polyimides and polyesters.
 5. The articleof claim 1 characterized by an absence of sprues and runners.